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MAROL 150MG PROLONGED-RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE

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muscles that control movement of the eye, agitation,
excessive sweating, tremor, exaggeration of reflexes,
increased muscle tension and body temperature
above 38°C.
(Tramadol hydrochloride)
• if you take coumarin anticoagulants (medicines for
blood thinning), such as warfarin, together with
PACKAGE LEAFLET: INFORMATION FOR THE USER
Marol Tablets. The effect of these medicines on blood
Read all of this leaflet carefully before you start taking
clotting may be affected and bleeding may occur.
this medicine because it contains important
• if you take tranquillizers, sleeping pills, other pain
information for you.
relievers such as morphine and codeine (also as
Keep this leaflet. You may need to read it again.
cough medicine), and alcohol while you are taking
If you have any further questions, ask your doctor or
Marol Tablets. You may feel drowsier or feel that you
pharmacist.
might faint. If this happens tell your doctor.
This medicine has been prescribed for you only. Do not
Taking
Marol Tablets with food and alcohol:
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
Do not drink alcohol during treatment with Marol
If you get any side effects talk to your doctor or
Tablets as its effect may be intensified. Food does not
pharmacist. This includes any possible side effects not influence the effect of Marol Tablets.
listed in this leaflet. See section 4.
Pregnancy, breast-feeding and fertility:

Marol 100 mg, 150 mg and 200 mg
Prolonged Release Tablets

What is in this leaflet:

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
1. What Marol Tablets are and what they are used for.
doctor or pharmacist for advice before taking this
2. What you need to know before you take Marol Tablets. medicine.
3. How to take Marol Tablets.
There is very little information regarding the safety of
4. Possible side effects.
tramadol in human pregnancy. Therefore you should
5. How to store Marol Tablets.
not use Marol Tablets if you are pregnant. Chronic use
6. Contents of the pack and other information.
during pregnancy may lead to withdrawal symptoms in
What
Marol
Tablets
are
and
what
they
are
newborns.
1

used for

Pharma Code
Positional

Generally, the use of Marol Tablets is not recommended
The name of your medicine is Marol 100 mg, 150 mg or during breast-feeding. Small amounts of tramadol are
200 mg Prolonged-release Tablets.
excreted into breast milk. On a single dose it is usually
Each prolonged release tablet contains 100 mg, 150 mg not necessary to interrupt breast-feeding. Please ask
your doctor for advice.
or 200 mg of tramadol hydrochloride. Tramadol, the
active substance is a pain killer belonging to the class
Driving and using machines:
of opioids that acts on the central nervous system.
Marol Tablets can cause drowsiness, dizziness, and
Marol Tablets relieve pain by acting on specific nerve
blurred vision and therefore may impair your reactions.
cells of the brain and spinal cord. Marol Tablets are
If you feel that your reactions are affected, do not drive
used for the treatment of moderate to severe pain.
a car or other vehicle, do not use electric tools or
operate machinery.
Marol Prolonged-release tablets are referred to as
Marol tablets below
The medicine can affect your ability to drive as it may
make you sleepy or dizzy.
What
you
need
to
know
before
you
take
2
• Do not drive while taking this medicine until you
Marol Tablets
know how it affects you.
Do not take Marol Tablets:
• It is an offence to drive if this medicine affects your
• If you are allergic to tramadol hydrochloride or any of
ability to drive.
the other ingredients of this medicine (listed in
• However, you would not be committing an offence if:
section 6).
o The medicine has been prescribed to treat a
• In acute poisoning with alcohol, sleeping pills, pain
medical or dental problem and
relievers, or other psychotropic medicines
o You have taken it according to the
(medicines that affect mood and emotions).
instructions given by the prescriber or in the
• If you are also taking MAO-inhibitors (certain
information provided with the medicine and
medicines used for treatment of depression) or have
o It was not affecting your ability to drive safely
taken them in the last 14 days before treatment with Talk to your doctor or pharmacist if you are not
Marol Tablets (see “Other medicines and Marol
sure whether it is safe for you to drive while
Tablets”).
taking this medicine.
• If you are epileptic and your fits are not adequately
controlled by treatment.
3 How to take Marol Tablets
• As a substitute in drug withdrawal.
Always use this medicine exactly as your doctor
Warnings and precautions:
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Talk to your doctor or pharmacist before taking Marol
The dosage should be adjusted to the intensity of your
Tablets if:
pain and your individual pain sensitivity. In general the
• You think that you are addicted to other pain
lowest pain-relieving dose should be taken.
relievers (opioids);
• You suffer from consciousness disorders (if you feel Unless otherwise prescribed by your doctor, the
recommended dose is:
that you are going to faint);
• You are in a state of shock (cold sweat may be a sign Adults and adolescents from the age of 12 years:
of this);
One Marol 100mg Tablet twice daily (equivalent to 200 mg
• You suffer from increased pressure in the brain
tramadol hydrochloride per day), preferably in the
(possibly after a head injury or brain disease);
morning and evening.
• You suffer from a liver or kidney disease;
• You have difficulty in breathing;
One Marol 150mg Tablet twice daily (equivalent to 300 mg
• You have a tendency towards epilepsy or fits because tramadol hydrochloride per day), preferably in the
the risk of a fit may increase.
morning and evening.
Epileptic fits have been reported in patients taking
One Marol 200mg Tablet twice daily (equivalent to 400 mg
tramadol at the recommended dose level. The risk may tramadol hydrochloride per day), preferably in the
be increased when doses of tramadol exceed the
morning and evening.
recommended upper daily dose limit (400 mg). Please
Your doctor may prescribe a different, more appropriate
note that Marol Tablets may lead to physical and
dosage strength of Marol Tablets if necessary.
psychological addiction. When Marol Tablets are taken
Do not take more than 400 mg tramadol hydrochloride
for a long time, its effect may decrease, so that higher
daily, except if your doctor has instructed you to do so.
doses have to be taken (tolerance development). In
patients with a tendency to abuse medicines or who
Use in children
are dependent on medicines, treatment with Marol
Tablets should only be carried out for short periods and Marol Tablets are not suitable for children below the
age of 12 years.
under strict medical supervision.
Please also inform your doctor if one of these problems Elderly patients
occurs during treatment with Marol Tablets or if they
applied in the past.
Other medicines and Marol Tablets:
Tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines. Marol Tablets
should not be taken together with MAO inhibitors
(certain medicines for the treatment of depression).
The pain relieving effect of Marol Tablets may be
reduced and the length of time it acts may be
shortened, if you also take medicines containing:
• Carbamazepine (for epileptic fits)
• Buprenorphine, nalbuphine, or pentazocine (pain
killers)
• Ondansetron (prevents nausea)

In elderly patients (above 75 years) the excretion of
tramadol may be delayed. If this applies to you, your
doctor may recommend prolonging the dosage interval.
Severe liver or kidney disease (insufficiency)/dialysis
patients
Patients with severe liver and/or kidney insufficiency
should not take Marol Tablets. If in your case the
insufficiency is mild or moderate, your doctor may
recommend prolonging the dosage interval.
How and when you should take Marol Tablets:

Marol Tablets are for oral use.
Always swallow Marol Tablets whole, not divided or
chewed, with sufficient liquid, preferably in the
morning and evening. You may take the tablets on an
Your doctor will tell you whether you should take Marol empty stomach or with meals.
Tablets and what dose.
How long should you take Marol Tablets:
The risk of side effects increases:
You should not take Marol Tablets for longer than
• if you are taking medicines which may cause
convulsions (fits), such as certain antidepressants or necessary. If you need to be treated for a longer period,
antipsychotics, the risk of having a fit may increase if your doctor will check at regular short intervals (if
you take Marol Tablets at the same time. Your doctor necessary with breaks in treatment) whether you
should continue to take Marol Tablets and at what dose.
will tell you whether Marol Tablets are suitable for
you.
If you have the impression that the effect of Marol
• if you are taking certain antidepressants. Marol
Tablets is too strong or too weak, talk to your doctor or
Tablets may interact with these medicines and you
pharmacist.
may experience symptoms such as involuntary,
rhythmic contractions of muscles, including the

If you take more Marol Tablets than you should:
If you have taken an additional dose by mistake, this
will generally have no negative effects. You should take
your next dose as prescribed.
After taking very high doses, pin-point pupils, vomiting,
fall in blood pressure, fast heart beat, collapse,
disturbed consciousness up to coma (deep
unconsciousness), epileptic fits, and difficulty in
breathing up to cessation of breathing may occur. In
such cases a doctor should be called immediately!
If you forget to take Marol Tablets
If you forgot to take the tablets, pain is likely to return.
Do not take a double dose to make up for forgotten
individual doses, simply continue taking tablets as
before.
If you stop taking Marol Tablets
If you interrupt or finish treatment with Marol Tablets
too soon, pain is likely to return. If you wish to stop
treatment on account of unpleasant effects, please tell
your doctor.
Generally there will be no after – effects when
treatment with Marol Tablets is stopped. However, on
rare occasions, people who have been taking Marol
Tablets for some time may feel unwell if they abruptly
stop taking them. They may feel agitated, anxious,
nervous or shaky. They may be confused, hyperactive,
have difficulty sleeping and have stomach or bowel
disorders. Very few people may get panic attacks,
hallucinations, delusions, paranoia or feeling a loss of
identity. They may experience unusual perceptions
such as itching, tingling and numbness, and “ringing”
in the ears (tinnitus). Further unusual CNS symptoms,
i.e. confusion, delusions, change of perception of their
own personality (depersonalisation), and change in
perception of reality (derealisation) and delusion of
persecution (paranoia) have been seen very rarely. If
you experience any of these complaints after stopping
Marol Tablets, please consult your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Usually the frequency of side effects is classified as
follows:
- very common (may affect more than 1 in 10 people),
- common (may affect up to 1 in 10 people),
- uncommon (may affect up to 1 in 100 people),
- rare (may affect up to 1 in 1,000 people)
- very rare (may affect up to 1 user in 10,000)
- not known (frequency cannot be estimated from the
available data).
You should see a doctor immediately if you experience
symptoms of an allergic reaction such as swollen face,
tongue and/or throat, and/or difficulty swallowing or
hives together with difficulties in breathing.

Common: being sick, constipation, dry mouth.
Uncommon: urge to vomit (retching), stomach trouble
(e.g. feeling of pressure in the stomach, bloating),
diarrhoea.
Skin disorders
Common: sweating.
Uncommon: skin reactions (e.g. itching, rash).
Muscle disorders
Rare: weak muscles.
Liver and biliary disorders
Very rare: increase in liver enzyme values.
Urinary disorders
Rare: passing urine with difficulty or pain, passing less
urine than normal
General disorders
Common: fatigue.
Rare: allergic reactions (e.g. difficulty breathing,
wheezing, swelling of the skin) and shock (sudden
circulatory failure) come in very rare cases.
If Marol Tablets are taken over a long period of time
dependence may occur, although the risk is very low.
When treatment is stopped abruptly signs of
withdrawal may appear (see “If you stop taking Marol
Tablets”).
Reporting of side effects
If you get any of the side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.

5

How to store Marol Tablets

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the blister and / or bottle and the carton after
“EXP”.The expiry date refers to the last day of that
month.
This medicinal product does not require any special
storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

6

Contents of the pack and other information

What Marol Tablets contain:
The active substance is: tramadol hydrochloride

Uncommon: effects on the heart and blood circulation
(pounding of the heart, fast heart beat, feeling faint or
collapse). These adverse effects may particularly occur
in patients in an upright position or under physical
strain.

• 1 Marol 100 mg tablet contains 100 mg tramadol
hydrochloride
• 1 Marol 150 mg tablet contains 150 mg tramadol
hydrochloride
• 1 Marol 200 mg tablet contains 200 mg tramadol
hydrochloride
The other ingredients are: calcium hydrogen phosphate
dihydrate (E341), hydroxypropyl cellulose (E463),
colloidal anhydrous silica (E551), and magnesium
stearate (E470b).

rare: slow heart beat, increase in blood pressure.

What Marol Tablets look like and contents of the pack

Metabolism and nutrition disorders

Marol 100mg Tablets are off white, round biconvex
tablets

The most common side effects during treatment with
Marol Tablets are nausea and dizziness, which occur in
more than in 1 in 10 patients.
Heart and blood circulation disorders

Not known: decrease in blood sugar level
Nervous system disorders
Very common: dizziness.
Common: headaches, drowsiness.
Rare: changes in appetite, abnormal sensations (e.g.
itching, tingling, numbness), trembling, slow breathing,
epileptic fits, muscle twitches, uncoordinated
movement, transient loss of consciousness (syncope).
If the recommended doses are exceeded, or if other
medicines that depress brain function are taken at the
same time, breathing may slow down.

Marol 150mg Tablets are off white, capsule shaped
tablets
Marol 200mg Tablets are off white, capsule shaped
tablets
All the strengths are available in either clear or opaque
coloured blister packs and pots of 10, 20, 30, 50, 60, 90,
100, 120, and 180 tablets but not all pack sizes may be
marketed.

Marketing Authorisation Holder:
Morningside Healthcare Ltd

115 Narborough Road Leicester LE3 0PA, UK

Epileptic fits have occurred mainly at high doses of
tramadol or when tramadol was taken at the same time Manufacturers:
FAL Duiven Dijkgraaf, 6921, RK Duiven, The Netherlands.
as other medicines which may induce fits.
Not known: speech disorders
Psychiatric disorders
Rare: hallucinations, confusion, sleep disorders,
anxiety and nightmares.
Psychological complaints may appear after treatment
with Marol Tablets. Their intensity and nature may vary
(according to the patient‘s personality and length of
therapy). These may appear as a change in mood
(mostly high spirits, occasionally irritated mood),
changes in activity (slowing down but sometimes an
increase in activity) and being less aware and less able
to make decisions, which may lead to errors in
judgment.

Medochemie Ltd, Facility A-Z, Ayios Athanassios,

Industrial Street, Limassol, Cyprus.

Morningside Pharmaceuticals Ltd
5 Pavilion Way Loughborough LE11 5GW, UK
This leaflet was last revised in March 2017.

Dependence may occur.
Eye disorders
Rare: blurred vision
Not known: extreme pupil dilation (mydriasis).
Respiratory disorders
Rare: shortness of breath (dyspnoea).
Worsening of asthma has been reported, however it
has not been established whether it was caused by
tramadol.
Stomach and bowel disorders
Very common: feeling sick.

87197-Y

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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